The SPIROCA

• Conditions: Fibromyalgia

• Registration Number: NL-OMON23499
• Lead Sponsor: eiden University Medical Center (LUMC)

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Female fibromyalgia patients will be included if they have a pain score ≥ 5 for most of the day and meet the 2010 American College of Rheumatology diagnostic criteria.

Exclusion Criteria

(i) Unable to give written informed consent; (ii) presence of medical disease that may alter PKPD of cannabinoids such as pulmonary, renal, liver, cardiac, gastro‐intestinal, vascular disease; (iii) allergy to study medication; (iv) use of strong opioids; (v) use of benzodiazepines; (vi) history of illicit drug abuse (incl. cannabisrelated products) or alcohol abuse; (vii) (family) history of psychosis; (viii) epilepsy; (ix) raised intracranial pressure;(x) pregnancy and/or lactation; (xi) the presence of pain syndromes other than fibromyalgia; (xii) age < 18 years.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PK data, spontaneous and experimental pain relief

Secondary Outcome Measures

Name	Time	Method
Mental state using Bowdle and Bond & Lader<br>questionnaires.